Shallow Vestibular DepthNCT05777811
The Relationship Between Root Coverage Procedures and Buccal Vestibular Depth
A study testing Vertically coronally advanced flap combined with connective tissue graft. and Free gingival graft in people with Shallow Vestibular Depth and Gingival Recession, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shallow Vestibular Depth, Gingival Recession
- What is being tested?
- Vertically coronally advanced flap combined with connective tissue graft. and Free gingival graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2021to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- full-mouth plaque and bleeding scores <15%
- the presence of at least one recession type-1/2 recession and at least one recession with recession depth ≥ 2 mm
- the presence of an identifiable cemento-enamel junction
Who cannot join
- Vestibule depth > 6mm
- Smoking > 10 cigarettes per day
- Any contraindications for periodontal surgery
- Unstable endodontic conditions or presence of any restoration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Recession Coverage Approaches on Sites With Shallow Vestibule Depth
In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. At baseline, 3rd-month, 6th-month, and 12th-month visits, the following parameters will be evaluated: buccal vestibular depth, keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level. Keratinized tissue change, gingival thickness change, root coverage, clinical attachment gain, and complete root coverage will be calculated. The wound healing index, tissue appearance, patient expectations, aesthetics, and dentin hypersensitivity will be assessed at baseline and at the 6th week.
Read the detailed description
Buccal vestibule depth was recorded using two different measurement methods. First, the distance between the cementoenamel junction and the deepest point of the vestibule sulcus was measured and recorded as VD1. Then, the distance between the gingival margin and the base of the vestibule sulcus was measured and recorded as VD2.
- Conditions
- Shallow Vestibular Depth, Gingival Recession
- Being tested
- Vertically coronally advanced flap combined with connective tissue graft., Free gingival graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertically coronally advanced flap combined with connective tissue graft.Procedure or surgery
The exposed root surfaces are planed with Gracey 1-2 curettes. An intrasulcular incision is made with a blade on the buccal aspects of the involved teeth. The incision is extended horizontally to the adjacent papilla. Then, slightly divergent vertical releasing incisions are carried 2 mm beyond the mucogingival junction. A full-thickness flap is raised with a periosteal elevator towards the mucogingival junction. After that, a partial-thickness dissection is carried out in the apical direction to release muscle tension and provide coronal advancement of the flap. The adjacent papillae are de-epithelialized. The connective tissue graft (CTG) is harvested from the lateral palate using the de-epithelialized gingival graft technique. After harvesting, the connective tissue graft is sutured to the recipient bed. Finally, the flap is positioned 2 mm over the cementoenamel junction and sutured with 6-0 polypropylene sutures. No periodontal dressing is applied.
Free gingival graftProcedure or surgery
Also called epithelialized free gingival graft
A partial-thickness flap is elevated (using a blade #15c) with horizontal incisions at the cemento-enamel junction (CEJ) level of the adjacent teeth. Then, two vertical incisions extending to the apical are made from the two ends of the horizontal incision. The epithelium in the framed region is removed with a scalpel, and the underlying connective tissue is exposed. To achieve the best vascularization of the free gingival graft from the recipient site, bed preparation is completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region. The free gingival graft is stabilized using interrupted sutures and a sling suture.
| Study group | Role | What they receive |
|---|---|---|
| Vertically Coronally advanced flap combined with connective tissue graft | Active comparator | Not described Receives: Procedure: Vertically coronally advanced flap combined with connective tissue graft. |
| Free Gingival Graft | Active comparator | Not described Receives: Procedure: Free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibule depth 2
The distance between the free gingival margin and the most apical point of the vestibul.
Measured: Baseline
Vestibule depth 2
The distance between the free gingival margin and the most apical point of the vestibul.
Measured: 3rd month
Vestibule depth 2
The distance between the free gingival margin and the most apical point of the vestibul.
Measured: 6th month
Vestibule depth 2
The distance between the free gingival margin and the most apical point of the vestibul.
Measured: 12th month.
Vestibule depth 1
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Measured: Baseline
Vestibule depth 1
The distance between the free semento enamel junction and the most apical point of the vestibul.
Measured: 3rd month
Vestibule depth 1
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Measured: 6th month
Vestibule depth 1
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Measured: 12th month
Secondary outcomes (25)
Recession depth (RD)
Measured as the distance from the cementoenamel junction to the gingival margin
Measured: Baseline
Recession depth (RD)
Measured as the distance from the cementoenamel junction to the gingival margin
Measured: 6th week
Recession depth (RD)
Measured as the distance from the cementoenamel junction to the gingival margin
Measured: 6th month.
Recession depth (RD)
Measured as the distance from the cementoenamel junction to the gingival margin
Measured: 12th month.
Probing depth (PD)
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Measured: Baseline
Probing depth (PD)
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Measured: 6th week
Probing depth (PD)
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Measured: 6th month
Probing depth (PD)
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Measured: 12th month.
Clinical attachment level (CAL)
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Measured: Baseline.
Clinical attachment level (CAL)
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Measured: 6th week
Clinical attachment level (CAL)
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Measured: 6th month
Clinical attachment level (CAL)
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Measured: 12th month.
Keratinized tissue height (KTH)
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Measured: Baseline.
Keratinized tissue height (KTH)
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Measured: 6th week
Keratinized tissue height (KTH)
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Measured: 6th month
Keratinized tissue height (KTH)
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Measured: 12th month.
Gingival thickness (GT)
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Measured: Baseline.
Gingival thickness (GT)
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Measured: 6th week.
Gingival thickness (GT)
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Measured: 6th month.
Gingival thickness (GT)
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Measured: 12th month.
Wound healing index (WHI)
Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.
Measured: 2nd week
Tissue appearance (TA)
Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.
Measured: 6th week
Dentine hypersensitivity (DH)
Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).
Measured: 6th week
Patient expectations (PE)
Patient expectations (PE) were evaluated by requesting from the patients to rate their treatment results at T2, as satisfactory or not, in terms of appearance, experience and obtained root coverage.
Measured: 6th week
Aesthetics (A)
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start3 Jan 2021
- Primary completion3 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shallow Vestibular DepthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gencay Keceli, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777811
- Sponsor's protocol ID
- Buccal Vestibule Depth
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parlak HM, Yilmaz BT, Durmaz MH, Toz H, Keceli HG. The effects of vertically coronally advanced flap and free gingival graft techniques on shallow vestibule: a randomized comparative prospective trial. Clin Oral Investig. 2023 Dec;27(12):7425-7436. doi: 10.1007/s00784-023-05332-4. Epub 2023 Oct 19.
PubMed 37855920
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Recession Coverage Approaches on Sites With Shallow Vestibule Depth
- ClinicalTrials.gov ID
- NCT05777811
- Acronym / sponsor ID
- Buccal Vestibule Depth
- Conditions
- Shallow Vestibular Depth, Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. At baseline, 3rd-month, 6th-month, and 12th-month visits, the following parameters will be evaluated: buccal vestibular depth, keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level. Keratinized tissue change, gingival thickness change, root coverage, clinical attachment gain, and complete root coverage will be calculated. The wound healing index, tissue appearance, patient expectations, aesthetics, and dentin hypersensitivity will be assessed at baseline and at the 6th week.
Detailed description
Buccal vestibule depth was recorded using two different measurement methods. First, the distance between the cementoenamel junction and the deepest point of the vestibule sulcus was measured and recorded as VD1. Then, the distance between the gingival margin and the base of the vestibule sulcus was measured and recorded as VD2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertically Coronally advanced flap combined with connective tissue graft | Active comparator | Procedure: Vertically coronally advanced flap combined with connective tissue graft. |
| Free Gingival Graft | Active comparator | Procedure: Free gingival graft |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- full-mouth plaque and bleeding scores <15%
- the presence of at least one recession type-1/2 recession and at least one recession with recession depth ≥ 2 mm
- the presence of an identifiable cemento-enamel junction
Key exclusion criteria (4 listed)
- Vestibule depth > 6mm
- Smoking > 10 cigarettes per day
- Any contraindications for periodontal surgery
- Unstable endodontic conditions or presence of any restoration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertically coronally advanced flap combined with connective tissue graft.The exposed root surfaces are planed with Gracey 1-2 curettes. An intrasulcular incision is made with a blade on the buccal aspects of the involved teeth. The incision is extended horizontally to the adjacent papilla. Then, slightly divergent vertical releasing incisions are carried 2 mm beyond the mucogingival junction. A full-thickness flap is raised with a periosteal elevator towards the mucogingival junction. After that, a partial-thickness dissection is carried out in the apical direction to release muscle tension and provide coronal advancement of the flap. The adjacent papillae are de-epithelialized. The connective tissue graft (CTG) is harvested from the lateral palate using the de-epithelialized gingival graft technique. After harvesting, the connective tissue graft is sutured to the recipient bed. Finally, the flap is positioned 2 mm over the cementoenamel junction and sutured with 6-0 polypropylene sutures. No periodontal dressing is applied. | Procedure or surgery | Vertically Coronally advanced flap combined with connective tissue graft |
| Free gingival graftAlso: epithelialized free gingival graftA partial-thickness flap is elevated (using a blade #15c) with horizontal incisions at the cemento-enamel junction (CEJ) level of the adjacent teeth. Then, two vertical incisions extending to the apical are made from the two ends of the horizontal incision. The epithelium in the framed region is removed with a scalpel, and the underlying connective tissue is exposed. To achieve the best vascularization of the free gingival graft from the recipient site, bed preparation is completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region. The free gingival graft is stabilized using interrupted sutures and a sling suture. | Procedure or surgery | Free Gingival Graft |
Primary outcome
Vestibule depth 2
Time frame: Baseline
The distance between the free gingival margin and the most apical point of the vestibul.
Vestibule depth 2
Time frame: 3rd month
The distance between the free gingival margin and the most apical point of the vestibul.
Vestibule depth 2
Time frame: 6th month
The distance between the free gingival margin and the most apical point of the vestibul.
Vestibule depth 2
Time frame: 12th month.
The distance between the free gingival margin and the most apical point of the vestibul.
Vestibule depth 1
Time frame: Baseline
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Vestibule depth 1
Time frame: 3rd month
The distance between the free semento enamel junction and the most apical point of the vestibul.
Vestibule depth 1
Time frame: 6th month
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Vestibule depth 1
Time frame: 12th month
The distance between the free semento-enamel junction and the most apical point of the vestibul.
25 secondary outcomes
Recession depth (RD)
Time frame: Baseline
Recession depth (RD)
Time frame: 6th week
Recession depth (RD)
Time frame: 6th month.
Recession depth (RD)
Time frame: 12th month.
Probing depth (PD)
Time frame: Baseline
Probing depth (PD)
Time frame: 6th week
Probing depth (PD)
Time frame: 6th month
Probing depth (PD)
Time frame: 12th month.
Clinical attachment level (CAL)
Time frame: Baseline.
Clinical attachment level (CAL)
Time frame: 6th week
Clinical attachment level (CAL)
Time frame: 6th month
Clinical attachment level (CAL)
Time frame: 12th month.
Keratinized tissue height (KTH)
Time frame: Baseline.
Keratinized tissue height (KTH)
Time frame: 6th week
Keratinized tissue height (KTH)
Time frame: 6th month
Keratinized tissue height (KTH)
Time frame: 12th month.
Gingival thickness (GT)
Time frame: Baseline.
Gingival thickness (GT)
Time frame: 6th week.
Gingival thickness (GT)
Time frame: 6th month.
Gingival thickness (GT)
Time frame: 12th month.
Wound healing index (WHI)
Time frame: 2nd week
Tissue appearance (TA)
Time frame: 6th week
Dentine hypersensitivity (DH)
Time frame: 6th week
Patient expectations (PE)
Time frame: 6th week
Aesthetics (A)
Time frame: 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 37855920Parlak HM, Yilmaz BT, Durmaz MH, Toz H, Keceli HG. The effects of vertically coronally advanced flap and free gingival graft techniques on shallow vestibule: a randomized comparative prospective trial. Clin Oral Investig. 2023 Dec;27(12):7425-7436. doi: 10.1007/s00784-023-05332-4. Epub 2023 Oct 19.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertically coronally advanced flap combined with connective tissue graft. and Free gingival graft in people with Shallow Vestibular Depth and Gingival Recession, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibule depth 2 (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05777811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.